Daewoong Pharmaceutical Launches Development of 'Adhesive Obesity Treatment'... Clinical Trials to Begin Early Next Year

GLP-1 Analog Microneedle Patch Formulation
Applied Once a Week... Increased User Convenience
Targeting Commercialization by 2028

Daewoong Pharmaceutical announced on the 6th that it will officially begin developing an obesity treatment in the form of a microneedle patch loaded with glucagon-like peptide (GLP)-1 analogs.

Daewoong Pharmaceutical's Microneedle Platform.
[Image courtesy of Daewoong Pharmaceutical]

Daewoong Pharmaceutical plans to start Phase 1 clinical trials of the microneedle patch obesity treatment early next year and commercialize it by 2028. The microneedle method, which involves attaching an ultra-small patch measuring 1㎠ to the arm or abdomen, is evaluated to enhance user convenience compared to existing formulations such as injections and oral medications.

GLP-1 analogs, which are attracting attention in the market as a "game changer" for obesity treatments, are components that exhibit similar actions to the incretin hormone GLP-1 secreted from the small intestine when food is ingested or blood sugar rises. GLP-1 analogs extend the half-life of the hormone GLP-1, which is only about 2 minutes. This suppresses appetite while slowing gastrointestinal peristalsis, allowing food to remain longer in the intestines and sustaining a feeling of fullness. Initially developed as a diabetes treatment by increasing insulin secretion and inhibiting glucagon secretion that raises blood sugar, these effects have led to an expansion of indications to obesity treatment.

Currently, most obesity treatments using GLP-1 analogs are developed as subcutaneous injections. Daily or weekly injection products are common, but patients face the inconvenience of self-administering injections. Additionally, exposure to room temperature for extended periods reduces efficacy, requiring strict refrigeration. Oral obesity treatments have very low bioavailability of about 1% and cause side effects such as vomiting, nausea, and diarrhea.

In contrast, the microneedle obesity treatment only needs to be applied once a week to areas with thin stratum corneum such as the arm or abdomen. It causes no pain as it does not stimulate nerve cells and has the same efficacy as existing injectable drugs. It can be stored at room temperature, eliminating the need for a cold chain system during distribution like injectable drugs. The microneedles attached to the body deliver GLP-1 drugs through microvessels.

Daewoong Pharmaceutical previously completed preclinical studies and secured related data on a microneedle patch of the GLP-1 analog "Semaglutide" series using its proprietary microneedle technology platform "Clopharm" through its R&D specialized affiliate Daewoong Therapeutics. Following technology transfer, Daewoong Pharmaceutical will begin Phase 1 clinical trials early next year.

Daewoong Therapeutics' Clopharm platform possesses technological capabilities demonstrated by filing six international patents and 23 domestic patents (five registered) in manufacturing, packaging, and other fields. Daewoong Therapeutics overcame the shortcomings of existing technologies related to drug uniformity, contamination prevention, and stability maintenance through a pressure drying process and complete adhesion packaging. Additionally, it has manufacturing technology that protects biodegradable microneedles, which are vulnerable to moisture and impact, in an intact state until the user applies them. The microneedles chosen by Daewoong Pharmaceutical for the obesity treatment formulation are of a dissolvable type that melts after administration to release the drug.

Daewoong Pharmaceutical plans to commercialize the microneedle patch obesity treatment by 2028. Global investment bank Morgan Stanley forecasts the global obesity treatment market to grow to 104 trillion won by 2030.

Daewoong Pharmaceutical also explained that the microneedle patch can improve patient treatment adherence. Patients receiving GLP-1 analogs have experienced increased appetite and weight gain upon discontinuing injectable treatments, making treatment adherence a key area for improvement. The microneedle formulation, which maintains efficacy for a week, could be a solution.

Seungho Jeon, CEO of Daewoong Pharmaceutical, stated, "Daewoong Pharmaceutical declared the '2030 Global Formulation No.1' vision last year and is focusing on microneedles, a new drug delivery route technology. We aim to address unmet needs of medical professionals and patients by developing a patch-type formulation of the globally spotlighted GLP-1 analog."

Meanwhile, Daewoong Therapeutics, which handled the preclinical process of this microneedle obesity treatment, is Daewoong Group’s specialized medical and pharmaceutical R&D affiliate established in February 2019. Its main business areas include ▲ delivery of peptide and protein drugs using the microneedle platform ▲ development of treatments for diabetic retinopathy and rare ocular diseases using ocular drug delivery technology ▲ development of synthetic lethal anticancer drugs and targeted protein degradation drugs in the small molecule new drug sector. In September, it received approval from the Ministry of Food and Drug Safety for a Phase 1 clinical trial (IND) to develop the world's first eye drop form diabetic retinopathy treatment using the main ingredient "Inavogliflozin" of the diabetes drug "Enblo."

This content was produced with the assistance of AI translation services.